Curhan et al1 report an increased risk of hypertension with use of NSAIDs in younger women based on an analysis of data collected from participants in the Nurses' Health Study II. Our experience in a recently completed double-blind randomized controlled trial of NSAID therapy for Alzheimer disease (unpublished data, 2003) provides evidence of risk of hypertension in older individuals.
In the trial, 351 individuals (mean age, 74 years; 53% women) with probable Alzheimer disease were randomly assigned to receive rofecoxib, 25 mg by mouth daily; naproxen sodium, 220 mg by mouth twice daily; or placebo for 1 year. Enrollment criteria required that subjects be medically stable. A history of hypertension was recorded for 115 subjects (33%); these subjects were balanced across the treatment groups. Mean ± SD systolic blood pressure at study entry was 134 ± 16 mm Hg and mean ± SD diastolic blood pressure was 75 ± 10 mm Hg, with no difference across treatment groups. Study visits were conducted at 1, 3, 6, 9, and 12 months after enrollment, with interval history, physical examination, and laboratory studies obtained at each visit. Any significant change in symptoms, physical examination findings, or laboratory values noted during or between study visits was captured as an adverse event.